Data Evaluating Combination Treatments Including REVLIMID®
Plus Antibody Therapies in Patients with Various Difficult-to-Treat
Forms of Non-Hodgkin Lymphoma Presented at the 54th
American Society of Hematology Annual Meeting

ABSTRACTS 689, 901, 3668, and 3692

December 11, 2012 05:41 PM Eastern Daylight Time

BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ:
CELG), announced results from several studies evaluating combination
treatment with REVLIMID® (lenalidomide) and antibody therapy
in non-Hodgkin lymphoma (NHL). The data were presented at the 54th
Annual Meeting of the American Society of Hematology (ASH) in Atlanta,
GA.

The presented data included two Phase II trials on the combination of
lenalidomide with R-CHOP, a Phase I/II trial evaluating the combination
of lenalidomide and ofatumumab, and a Phase II trial analyzing the
combination of lenalidomide and rituximab.

Another Phase II trial (abstract #3668) evaluated the clinical activity
of lenalidomide as maintenance therapy following R-CHOP in patients with
diffuse large B-cell lymphoma who achieved a complete response to the
chemotherapy regimen. At a median follow up of 24 months, patients who
received maintenance lenalidomide achieved a median two-year PFS rate of
92%, compared with 83% for patients treated with lenalidomide plus
rituximab as maintenance; overall survival rates were 92% and 77%,
respectively. Grade ≥3 toxicities include neutropenia (25%), fatigue
(15%), hypothyroidism (5%), deep-vein thrombosis (3%), and rash (3%).

A phase I/II trial (abstract #3692) evaluated lenalidomide in
combination with ofatumumab in patients with relapsed/refractory B-cell
NHL. Patients in this trial with follicular lymphoma demonstrated an ORR
of 83% and a one-year PFS of 67%. Overall, grade 4 neutropenia occurred
in 24% (9/37) of patients, and one case occurred for each of grade 4
bacteremia, grade 4 deep vein thrombosis, stroke, and acute renal
failure.

Lastly, final results of a Phase II trial (abstract #901) evaluated
lenalidomide plus rituximab in patients with advanced stage, untreated
indolent NHL, with an ORR of 90%. In the study, the estimated three-year
PFS was 78%. Grade ≥3 neutropenia occurred in 41% of patients, and
thrombocytopenia in 6% of patients. The most common grade ≥3
non-hematologic toxicities included muscle pain (8%), rash (7%), and
fatigue (5%), thrombosis (3%) and other pulmonary events (4%). Five
patients developed neutropenic fever.

These data are from investigational studies. REVLIMID® is not
approved for use in patients with non-Hodgkin lymphoma.

About REVLIMID

REVLIMID is an IMiDs® compound. REVLIMID and other
IMiDs continue to be evaluated in over 300 clinical trials worldwide.
The IMiDs pipeline is covered by a comprehensive intellectual property
estate of issued and pending patent applications in the US, EU and other
regions, including composition-of- matter and use patents.

REVLIMID is approved in combination with dexamethasone for the treatment
of patients with multiple myeloma who have received at least one prior
therapy in nearly 70 countries, encompassing Europe, the Americas, the
Middle-East and Asia, and in combination with dexamethasone for the
treatment of patients whose disease has progressed after one therapy in
Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland,
Australia, New Zealand and several Latin American countries, as well as
Malaysia and Israel, for transfusion-dependent anaemia due to low- or
intermediate-1-risk MDS associated with a deletion 5q cytogenetic
abnormality with or without additional cytogenetic abnormalities.
Marketing Authorization Applications are currently being evaluated in a
number of other countries.

Since 1998, Celgene continues to be a pioneer in creating environments
in which patients can benefit from our disease-altering therapies
safely. As a result, hundreds of thousands of patients worldwide have
accessed the clinical benefits of our therapies through our
performance-based risk management programs including, S.T.E.P.S.®,
RevAssist® and RevMate®, which form the foundation
of our commitment to patient safety.

U.S. Regulatory Information for Revlimid

REVLIMID® (lenalidomide) in combination with
dexamethasone is indicated for the treatment of patients with multiple
myeloma (MM) who have received at least one prior therapy.

REVLIMID® (lenalidomide) is indicated for
the treatment of patients with transfusion-dependent anemia due to low-
or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a
deletion 5q cytogenetic abnormality with or without additional
cytogenetic abnormalities.

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide
analogue, caused limb abnormalities in a developmental monkey study.
Thalidomide is a known human teratogen that causes severe
life-threatening human birth defects. If lenalidomide is used during
pregnancy, it may cause birth defects or death to a developing baby. In
women of childbearing potential, obtain 2 negative pregnancy tests
before starting REVLIMID treatment. Women of childbearing potential must
use 2 forms of contraception or continuously abstain from heterosexual
sex during and for 4 weeks after REVLIMID treatment. To avoid fetal
exposure to lenalidomide, REVLIMID is only available under a restricted
distribution program called “RevAssist®.”

Information about the RevAssist program is available at www.REVLIMID.com
or by calling the manufacturer’s toll-free number 1-888-423-5436.

HEMATOLOGIC TOXICITY (NEUTROPENIA AND
THROMBOCYTOPENIA)

REVLIMID can cause significant neutropenia and thrombocytopenia.
Eighty percent of patients with del 5q MDS had to have a dose
delay/reduction during the major study. Thirty-four percent of patients
had to have a second dose delay/reduction. Grade 3 or 4 hematologic
toxicity was seen in 80% of patients enrolled in the study. Patients on
therapy for del 5q MDS should have their complete blood counts monitored
weekly for the first 8 weeks of therapy and at least monthly thereafter.
Patients may require dose interruption and/or reduction. Patients may
require use of blood product support and/or growth factors. (see DOSAGE
and ADMINISTRATION)

DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

REVLIMID has demonstrated a significantly increased risk of deep vein
thrombosis (DVT) and pulmonary embolism (PE) in patients with MM who
were treated with REVLIMID and dexamethasone therapy. Patients and
physicians are advised to be observant for the signs and symptoms of
thromboembolism. Patients should be instructed to seek medical care if
they develop symptoms such as shortness of breath, chest pain, or arm or
leg swelling. It is not known whether prophylactic anticoagulation or
antiplatelet therapy prescribed in conjunction with REVLIMID may lessen
the potential for venous thromboembolic events. The decision to take
prophylactic measures should be done carefully after an assessment of an
individual patient’s underlying risk factors.

CONTRAINDICATIONS:

Pregnancy Category X:

Lenalidomide is contraindicated in pregnant women and women capable of
becoming pregnant. Females of childbearing potential may be treated
with lenalidomide provided adequate precautions are taken to avoid
pregnancy

REVLIMID is an analogue of thalidomide, a known human teratogen that
causes life-threatening human birth defects. An embryofetal
development study in non-human primates indicates that lenalidomide
produced malformations in the offspring of female monkeys who received
the drug during pregnancy, similar to birth defects observed in humans
following exposure to thalidomide during pregnancy. If REVLIMID is
used during pregnancy, it may cause birth defects or death to a
developing baby

Females of childbearing potential must be advised to avoid pregnancy
while on REVLIMID. Two effective contraceptive methods must be used by
female patients of childbearing potential for at least 4 weeks before
beginning REVLIMID therapy, during therapy, during dose interruptions
and for 4 weeks following discontinuation of REVLIMID therapy

Male Patients: Clinical data has demonstrated the presence of
lenalidomide in human semen. Male patients taking REVLIMID should not
donate sperm. Males receiving REVLIMID must always use a latex condom
during any sexual contact with females of childbearing potential, even
if they have undergone a successful vasectomy

Because of this potential toxicity and to avoid fetal exposure,
REVLIMID is only available under a special restricted distribution
program called “RevAssist.” Prescribers and pharmacists registered
with the program can prescribe and dispense the product to patients
who are registered and meet all the conditions of the RevAssist program

Hematologic Toxicity—Multiple Myeloma:

REVLIMID can cause significant neutropenia and thrombocytopenia

Patients taking REVLIMID for MM should have their complete blood
counts monitored every 2 weeks for the first 12 weeks and then monthly
thereafter

In the pooled MM studies Grade 3 and 4 hematologic toxicities were
more frequent in patients treated with the combination of REVLIMID and
dexamethasone than in patients treated with dexamethasone alone

Angioedema and serious dermatologic reactions including
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
have been reported. These events can be fatal. Patients with a prior
history of Grade 4 rash associated with thalidomide treatment should
not receive REVLIMID. REVLIMID interruption or discontinuation should
be considered for Grade 2-3 skin rash. REVLIMID must be discontinued
for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS
or TEN is suspected, and should not be resumed following
discontinuation for these reactions

REVLIMID capsules contain lactose. Risk-benefit of REVLIMID treatment
should be evaluated in patients with lactose intolerance

Tumor Lysis Syndrome:

Fatal instances of tumor lysis syndrome have been reported during
treatment with lenalidomide. The patients at risk of tumor lysis
syndrome are those with high tumor burden prior to treatment. These
patients should be monitored closely and appropriate precautions taken

Tumor Flare Reaction:

Tumor flare reaction has occurred during investigational use of
lenalidomide for chronic lymphocytic leukemia (CLL) and lymphoma, and
is characterized by tender lymph node swelling, low grade fever, pain
and rash. Treatment of CLL or lymphoma with lenalidomide outside of a
well-monitored clinical trial is discouraged

Hepatotoxicity:

Cases of transient liver laboratory abnormalities (predominantly
transaminases) were reported in patients treated with lenalidomide.
Treatment with lenalidomide should be interrupted and restarted once
the levels return to baseline. Successful re-challenge without
recurrence of liver laboratory elevation was reported in some patients

Second Primary Malignancies

Patients with MM treated with lenalidomide in studies including
melphalan and stem cell transplantation had a higher incidence of
second primary malignancies, particularly acute myelogenous leukemia
(AML) and Hodgkin lymphoma, compared to patients in the control arms
who received similar therapy but did not receive lenalidomide. Monitor
patients for the development of second malignancies. Take into account
both the potential benefit of lenalidomide and the risk of second
primary malignancies when considering treatment with lenalidomide

DRUG INTERACTIONS:

Periodic monitoring of digoxin plasma levels, in accordance with
clinical judgment and based on standard clinical practice in patients
receiving this medication, is recommended during administration of
REVLIMID

It is not known whether there is an interaction between dexamethasone
and warfarin. Close monitoring of PT and INR is recommended in MM
patients taking concomitant warfarin

Erythropoietic agents, or other agents, that may increase the risk of
thrombosis, such as estrogen containing therapies, should be used with
caution in MM patients receiving lenalidomide with dexamethasone

USE IN SPECIFIC POPULATIONS:

Nursing Mothers:

It is not known whether REVLIMID is excreted in human milk

Because of the potential for adverse reactions in nursing infants, a
decision should be made whether to discontinue nursing or the drug,
taking into account the importance of the drug to the mother

Geriatric Use:

Since elderly patients are more likely to have decreased renal
function, care should be taken in dose selection Monitor renal function

Renal Impairment:

Since REVLIMID is primarily excreted unchanged by the kidney,
adjustments to the starting dose of REVLIMID are recommended to
provide appropriate drug exposure in patients with moderate (CLcr
30-60 mL/min) or severe renal impairment (CLcr < 30 mL/min) and in
patients on dialysis

ADVERSE REACTIONS:

Multiple Myeloma

In the REVLIMID/dexamethasone treatment group, 269 patients (76%)
underwent at least one dose interruption with or without a dose
reduction of REVLIMID compared to 199 patients (57%) in the
placebo/dexamethasone treatment group

Of these patients who had one dose interruption with or without a dose
reduction, 76% (269/353) vs 57% (199/350), 50% in the
REVLIMID/dexamethasone treatment group underwent at least one
additional dose interruption with or without a dose reduction compared
to 21% in the placebo/dexamethasone treatment group

Most adverse events and Grade 3/4 adverse events were more frequent in
MM patients who received the combination of REVLIMID/dexamethasone
compared to placebo/dexamethasone

Deep vein thrombosis (DVT) was reported as a serious adverse drug
reaction (7.4%) or Grade 3/4 (8.2%) compared to 3.1% and 3.4%.
Discontinuations due to DVT were reported at comparable rates between
groups

Pulmonary embolism (PE) was reported as a serious adverse drug
reaction (3.7%) or Grade 3/4 (4.0%) compared to 0.9% and 0.9%.
Discontinuations due to PE were reported at comparable rates between
groups

Treatment is continued or modified based upon clinical and laboratory
findings. Dosing modifications are recommended to manage Grade 3 or 4
neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged
to be related to REVLIMID

For other Grade 3 or 4 toxicities judged to be related to REVLIMID,
hold treatment and restart at next lower dose level when toxicity has
resolved to ≤Grade 2

Please see full Prescribing Information, including Boxed WARNINGS,
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

About Non-Hodgkin Lymphoma

Lymphoma is the name for the group of blood cancers that start in the
lymphatic system, which is part of the body’s immune system. Lymphomas
generally start in the lymph nodes or lymphatic tissue in sites of the
body such as the stomach or intestines. They may involve the marrow and
the blood in some cases as well. Most people with lymphoma have one of
the many different kinds of non-Hodgkin’s lymphoma (NHL) and there are
an estimated 360,000 cases of NHL in the U.S. with more than 59,000 new
cases diagnosed annually.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of
Neuchâtel, Switzerland, is a wholly owned subsidiary and international
headquarters of Celgene Corporation. Celgene Corporation, headquartered
in Summit, New Jersey, is an integrated global pharmaceutical company
engaged primarily in the discovery, development and commercialization of
innovative therapies for the treatment of cancer and inflammatory
diseases through gene and protein regulation. For more information,
please visit the Company's website at www.celgene.com.

Forward-Looking Statements

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generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," “outlook” and
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speak only as of the date they are made. We undertake no obligation to
update any forward-looking statement in light of new information or
future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are
difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual Report
on Form 10-K and our other reports filed with the Securities and
Exchange Commission.

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